MADE BY DENTISTS FOR KIDS MONSTER SLIME- sodium fluoride paste

Made by Dentists For Kids Monster Slime by

Drug Labeling and Warnings

Made by Dentists For Kids Monster Slime by is a Otc medication manufactured, distributed, or labeled by Fulijaya Manufacturing Sdn. Bhd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient:

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity 

Use:

Aids in the prevention of cavities.

Warnings:

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentlly swallowed, get medical help or contact a Poison Control Center right away.

Directions:

• Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
• Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing), and only use a pea size amount.
• Supervise children as necessary until capable of using without supervision.
• Children under 2 years of age: Consult a dentist or doctor.

Inactive ingredients:

Sorbitol, Water (Aqua), Hydrated Silica, Glycerin, Xylitol, Cellulose Gum, Cocamidopropyl Betaine, Potassium Sorbate, Stevia Rebaudiana Leaf Extract, Chlorophyllin-Copper Extract, Bixa orellana Seed Extract

Questions or comments?

+ 1 (646) 980-6461

Label

INGREDIENTS AND APPEARANCE

MADE BY DENTISTS FOR KIDS MONSTER SLIME 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62776-002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
BIXA ORELLANA SEED (UNII: O87354RZ5A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62776-002-01	1 in 1 CARTON	01/01/2024
1		120 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/01/2024

Labeler - Fulijaya Manufacturing Sdn. Bhd (652087115)

Establishment
Name	Address	ID/FEI	Business Operations
Fulijaya Manufacturing Sdn. Bhd		652087115	manufacture(62776-002)